Long-Term Opioid Addiction, Overdose Risks Emphasized on New FDA Label Warnings

An FDA advisory committee is warning that prolonged opioid use in chronic pain patients carries serious risks of misuse, addiction and overdose.

According to federal regulators, many opioid medications have been approved for long-term use without adequate clinical data to support their safety, despite widespread use in treating chronic pain.

In a press release issued on July 31, the U.S. Food and Drug Administration (FDA) shared findings from a May advisory committee meeting, which revealed significant gaps in long-term safety research on prescription opioid use.

Opioids are a class of both prescription and illegal drugs, primarily used to alleviate pain. They include products that are derived naturally from the poppy plant, like morphine and codeine, as well as manufactured synthetically in laboratories, like fentanyl.

Some prescription opioid pain medications, including OxyContin, Percocet, Vicodin and others, have played a major role in the U.S. opioid abuse crisis, which led to at least 80,000 overdose deaths in 2023 alone, according to the U.S. Centers for Disease Control and Prevention (CDC).

On May 5, 2025, the FDA convened a public advisory committee meeting to review studies on the risks of misuse, abuse, addiction and overdose among patients who have been prescribed opioids for chronic pain management.

Following the meeting, federal regulators are requiring a series of updates be made to warning labels on many prescription opioid medications. These include adding:

• Clearer addiction and overdose data: Labels will now include a summary of study findings on the risks of addiction, misuse and overdose associated with long-term use.
• Revised duration of use language: Previous language suggesting indefinite use has been removed to avoid misinterpretation about safety over extended periods.
• Stronger dose-related warnings: Labels will emphasize that higher doses increase the risk of serious side effects, and that these risks persist over time.
• Clarified use for long-acting opioids: Extended-release formulations should only be prescribed when other treatments, including short-acting opioids, have failed to provide adequate relief.
• Safe tapering recommendations: Labels will caution against abruptly stopping opioids in physically dependent patients, due to the risk of withdrawal or other harm.
• Expanded overdose reversal guidance: Additional information will be included about medications that can counteract the effects of an opioid overdose.
• Enhanced drug interaction warnings: The list of high-risk drug combinations now includes gabapentinoids, which can increase central nervous system depression.
• Toxic leukoencephalopathy risk: Labels will mention this rare but serious brain condition as a potential outcome of opioid overdose.
• Digestive system complications: New warnings will address opioid-related issues affecting the esophagus.

The FDA also noted that some opioids, including OxyContin, were approved without data on their long-term use for chronic pain, even though more recent evidence links extended use to addiction, overdose and death.

“The death of almost one million Americans during the opioid epidemic has been one of the cardinal failures of the public health establishment. This long-overdue labeling change is only part of what needs to be done — we also need to modernize our approval processes and post-market monitoring so that nothing like this ever happens again.”

-Marty Makary, M.D., M.P.H., FDA Commissioner

An FDA drug safety communication provides a detailed summary of the agency’s recent findings. The agency has also sent letters to all affected manufacturers, outlining the required label changes and giving them 30 days to submit updated materials for review.

Opioid Addiction Crisis

This is not the first time federal regulators have taken action to warn the medical community and patients about the growing opioid addiction crisis.

In 2016, the FDA announced new black box labels for certain opioids, including OxyContin and hydrocodone, to warn about the risks of misuse, abuse, addiction, overdose and death. This move followed the announcement of new opioid use guidelines by the CDC earlier that same year.

Both actions were taken in direct response to the growing opioid use epidemic, which has often been linked to aggressive promotions by drug manufacturers and the prescribing habits of doctors, who were giving patients prescriptions for narcotic painkillers, like Percocet and Tramadol, without a pain diagnosis in more than 30% of cases.

As the opioid epidemic has reached dramatic proportions, many individuals have sought the aid of prescription drugs, like Suboxone, to help wean them from their addictions.

While Suboxone has aided withdrawal management for many individuals, the drug’s reformulated dental strips have also sparked legal challenges. More than 10,000 Suboxone lawsuits have been filed in recent years, claiming that the manufacturer placed profits above consumer safety, by failing to adequately research tooth decay and tooth loss side effects from Suboxone strips, resulting in widespread dental harm for many former addicts.

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